Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Plasma Glucose and Insulin Responses After Consumption of Breakfasts With Different Sources of Soluble Fiber in Type 2 Diabetes Patients: a Randomized Crossover Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204384
• Other study ID #: 140161
• Status: Completed
• Phase: N/A
• First received: July 28, 2014
• Last updated: February 13, 2017
• Start date: August 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The hypothesis is a meal with a high content of soluble fiber from food determines glycemic and insulinemic response similar to a meal with a high content of soluble fiber from supplement sources.

Description:

Three breakfasts (high amount of fiber from diet food sources - HFD, high amount of soluble fiber from guar gum supplement - HFS and usual amount of fiber -UF), isocaloric and similar distribution of carbohydrates, proteins and lipids, the order of breakfasts randomly determined. Meals HFD and HFS have the same amount of fiber from different sources, origin in food and supplement respectively. Meal UF consist of the same foods meal HFS, but without the use of soluble fiber supplement and white bread instead of rye bread (low fiber content in relation to meals HFD and HFS). The supplement (Sachet 5g - Fiber Mais ®: 60% guar gum and 40% inulin) will be added to the plain water to meal HFD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes

• Body Mass Index (BMI) <= 35 kg / m²

• Hemoglobin A1c (HbA1c) <= 9%

Exclusion Criteria:

• Serum creatinine >2.0 mg/dL

• Digestive diseases (e.g. malabsorption)

• Severe autonomic neuropathy (presence of symptomatic postural hypotension, gastroparesis, diabetic diarrhea)

• Recent cardiovascular event

• Cachexia

• Psychiatric disorder with impairment of understanding

• Participating in other research protocol

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Diabetic Blood Glucose Monitoring
• Dietary Modification
• Insulin Tolerance

Intervention

Other:
• HFD Meal: High fiber from food
High amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g)

Dietary Supplement:
• HFS Meal: High fiber from supplement
High amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - sachet 5 g Fiber Mais, Nestlé Brasil, São Paulo, BR

Other:
• UF Meal: usual amount of fiber
Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses		Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal